Diagnosis and anti-Mullerian hormone (AMH) administration for treatment of infertility for good-, intermediate- and poor-prognosis patients for in vitro fertilization in view of logistic regression models

Abstract

Method of diagnosis of IVF viability. The method includes ascertaining a subject's AMH level from testing and then selecting one pregnancy or live birth prognosis category that applies to the ascertained AMH level by matching the ascertained AMH level with an applicable one of a plurality of ranges of AMH levels pertaining to an age of the subject. The matching indicates the prognosis category that applies, i.e., (that is, good, intermediate or poor. In view of the diagnosis, a method of administration of AMH may be pursued to increase probability of pregnancy or live birth chances. Alternatively, the administration of AMH may be at AMH levels that will terminate pregnancy or increase the chance of miscarriage.

What is claimed is: 
     
       1. A method of increasing a pregnancy rate in a subject, comprising:
 accessing an analysis tool that identifies an applicable one of different prognosis categories each containing a corresponding success percentage for an ascertained anti-Mü llerian hormone (AMH) level of a subject based upon the age of the subject, wherein the analysis tool:
 sets forth a success percentage that is correlated with an AMH level based upon an applicable age group, 
 assigns the success percentage as applicable to one of a live birth rate, a live birth probability, a pregnancy rate with in vitro fertilization and a pregnancy probability with in vitro fertilization, and 
 categorizes the assigned success percentage into an associated grouping for an applicable one of different prognosis categories; 
 
 making a diagnosis by retrieving the associated grouping from the accessed analysis tool so as to provide a prognosis for increasing the pregnancy rate in the subject; 
 administering to the subject a composition having an effective amount of AMH protein to achieve and maintain the AMH level of between 3.5-8.5 ng/ml within the subject, wherein the effective amount of AMH in accord with the prognosis; and 
 adjusting, over time, the effective amount of the AMH protein within the composition being administered accordingly to maintain the AMH level of between 3.5-8.5 ng/ml within the subject through testing of the AMH level of the subject over time 
 wherein the composition comprises SEQ ID NO: 1. 
 
     
     
       2. The method of  claim 1 , wherein for each of the different prognosis categories, associating the associated grouping with a respective range of AMH levels in correspondence with an applicable one of the age groups. 
     
     
       3. The method of  claim 1 , further comprising:
 selecting the different prognosis categories from the group consisting of good, intermediate and poor prognosis categories; wherein the good prognosis category has a higher probability of pregnancy success with in vitro fertilization than that of the intermediate and poor prognosis categories, the poor prognosis category has a worse probability of pregnancy success with in vitro fertilization than that of the intermediate and good prognosis categories, and the intermediate prognosis category has a probability of pregnancy success with in vitro fertilization that is between that for the poor and good prognosis categories. 
 
     
     
       4. The method of  claim 3 , wherein the good prognosis category pertains to pregnancy probability and is in accord with AMH level ranges of: 3.5 to 8.5 ng/ml inclusive encompassing the ascertained AMH level for the subject that is under 36 years old, 4.5 to 7.5 ng/ml inclusive encompassing the ascertained AMH level for the subject that is 36 to 38 years old inclusive, 5.0 to 7.0 ng/ml inclusive encompassing the ascertained AMH level for the subject that is 39 to 42 years old inclusive, and 4.5 to 7.5 ng/ml inclusive encompassing the ascertained AMH level for the subject that is over 42 years old. 
     
     
       5. The method of  claim 3 , wherein the intermediate prognosis category pertains to pregnancy probability and is in accord with any of AMH level ranges of only: both a range of 1.0 to 3.0 ng/ml inclusive and a range of 9.0 to 10.0 ng/ml inclusive for encompassing the ascertained AMH level for the subject that is under 36 years old, both a range of 2.5 to 4.0 ng/ml inclusive and a range of 8.0 to 10.0 ng/ml inclusive for encompassing the ascertained AMH level for the subject that is 36 to 38 years old inclusive, both a range of 1.5 to 4.5 ng/ml inclusive and a range of 7.5 to 10.0 ng/ml inclusive for encompassing the ascertained AMH level for the subject that is 39 to 40 years old inclusive, both a range of 2.5 to 4.5 ng/ml inclusive and a range of 7.5 to 10.0 ng/ml for encompassing the ascertained AMH level for the subject that is 41 to 42 years old inclusive, and both a range of 3.0 to 4.0 ng/ml inclusive and a range of 8.0 to 10.0 ng/ml inclusive for encompassing the ascertained AMH level for the subject that is over 42 years old. 
     
     
       6. The method of  claim 3 , wherein the poor prognosis category pertains to pregnancy probability and is in accord with AMH level ranges of: a range of 0.0 to 0.5 ng/ml inclusive for encompassing the ascertained AMH level for the subject that is under 36 years old, a range of 0.0 to 2.0 ng/ml inclusive for encompassing the ascertained AMH level for the subject that is 36 to 38 years old inclusive, a range of 0.0 to 1.0 ng/ml inclusive for encompassing the ascertained AMH level for the subject that is 39 to 40 years old inclusive, a range of 0.0 to 2.0 ng/ml inclusive for encompassing the ascertained AMH level for the subject that is 41 to 42 years old inclusive, and a range of 0.0 to 2.5 ng/ml inclusive for encompassing the ascertained AMH level for the subject that is over 42 years old. 
     
     
       7. The method of  claim 1 , wherein the administering occurs for a period of time and with dosages, the period of time being selected from the category consisting of about 1 day to about 180 days, 10 days to about 120 days and 30 days to about 90 days, and the dosages being within a range selected from the category consisting of about 100 ng per day to about 44,000 ng per day, and about 22,000 ng per day to about 44,000 ng per day. 
     
     
       8. The method of  claim 1 , further comprising:
 ceasing the administering after a period of time; inducing superovulation in the subject after the period of time ends; and 
 resuming the administrating administering as warranted to maintain the AMH level after a further period of time elapses subsequent to commencement of inducing superovulation. 
 
     
     
       9. The method of  claim 8 , wherein the inducing superovulation in the subject is carried out by administering to the subject at least one agent selected from the category consisting of follicle stimulating hormone (FSH), luteinizing hormone (LH), clomiphene, a selective estrogen-receptor modulator (SERM) and an aromatase inhibitor. 
     
     
       10. The method of  claim 1 , wherein the administering to the subject of the effective amount of AMH to achieve and maintain the AMH level is within a range of: 3.5-8.5 ng/ml for the subject being under 36 years old; 4.5-7.5 ng/ml for the subject being 36-38 years old inclusive; 5.0-7.0 ng/ml for the subject being 39-42 years old inclusive; and 4.5-7.5 ng/ml for the subject being over 42 years old. 
     
     
       11. A method of increasing a live birth rate in a subject, comprising:
 accessing an analysis tool that identifies an applicable one of different prognosis categories each containing a corresponding success percentage for an ascertained anti-Mü llerian hormone (AMH) level of a subject based upon the age of the subject, wherein the analysis tool:
 sets forth a success percentage that is correlated with an AMH level based upon an applicable age group, 
 assigns the success percentage as applicable to a live birth rate, a live birth probability, a pregnancy rate with in vitro fertilization and a pregnancy probability with in vitro fertilization, and 
 categorizes the assigned success percentage into an associated grouping for an applicable one of different prognosis categories; 
 
 making a diagnosis by retrieving the associated grouping from the accessed analysis tool so as to provide a prognosis for increasing the live birth rate in the subject; and 
 administering to the subject a composition having an effective amount of AMH protein in accord with the prognosis to achieve and maintain the AMH level over time of between: 5.0-6.5 ng/ml inclusive for the subject who is between 39-42 years old, 4.5-6.5 ng/ml inclusive for the subject who is between 36-38 years old, and 3.5-7.0 ng/ml for the subject who is under  36  years old, 
 wherein the composition comprises SEQ ID NO: 1. 
 
     
     
       12. The method of  claim 11 , further comprising:
 selecting the different prognosis categories from the group consisting of good, intermediate and poor prognosis categories, wherein the good prognosis category has a higher probability of live birth success than that of the intermediate and poor prognosis categories, the poor prognosis category has a worse probability of live birth success than that of the intermediate and good prognosis categories, and the intermediate prognosis category has a probability of live birth success that is between that for the poor and good prognosis categories. 
 
     
     
       13. The method of  claim 12 , wherein the good prognosis category pertains to live birth probability and is in accord with AMH level ranges of: a range of 3.5 to 7.0 ng/ml inclusive for encompassing the ascertained AMH level for the subject that is under 36 years old, a range of 4.5 to 6.5 ng/ml inclusive for encompassing the ascertained AMH level for the subject that is 36 to 38 years old inclusive, and a range of 5.0 to 6.5 ng/ml inclusive for encompassing the ascertained AMH level for the subject that is 39 to 42 years old inclusive. 
     
     
       14. The method of  claim 12 , wherein the intermediate prognosis category pertains to live birth probability and is in accord with AMH level ranges of: both a range of  1 .5 to 3.0 ng/ml inclusive and a range of 7.5 to 9.0 ng/ml inclusive for encompassing the ascertained AMH level for the subject that is under 36 years old, both a range of 2.5 to 4.0 ng/ml inclusive and a range of 7.0 to 8.5 ng/ml inclusive for encompassing the ascertained AMH level for the subject that is 36 to 38 years old inclusive, both a range of 2.0 to 4.5 ng/ml inclusive and a range of 7.0 to 8.5 ng/ml inclusive for encompassing the ascertained AMH level for the subject that is 39 to 40 years old inclusive, and both a range of 2.0 to 4.5 ng/ml inclusive and a range of 7.0 to 8.5 ng/ml for encompassing the ascertained AMH level for the subject that is 41 to 42 years old inclusive. 
     
     
       15. The method of  claim 12 , wherein the poor prognosis category pertains to live birth probability and is in accord with AMH level ranges of: both a range of 0.0 to 1.0 ng/ml inclusive and a range of 9.5 to 10.0 ng/ml inclusive for encompassing the ascertained AMH level for the subject that is under 36 years old, both a range of 0.0 to 2.0 ng/ml inclusive and a range of 9.0 to 10.0 ng/ml inclusive for encompassing the ascertained AMH level for the subject that is 36 to 38 years old inclusive, both a range of 0.0 to 1.5 ng/ml inclusive and a range of 9.0 to 10.0 ng/ml inclusive for encompassing the ascertained AMH level for the subject that is 39 to 42 years old inclusive, and a range of 0.0 to 10.0 ng/ml inclusive for encompassing the ascertained AMH level for the subject that is over 42 years old. 
     
     
       16. A method of terminating pregnancy or increasing miscarriage rate in a subject, comprising:
 accessing an analysis tool that identifies an applicable one of different prognosis categories each containing a corresponding success percentage for an ascertained anti-Mü llerian hormone (AMH) level of a subject based upon the age of the subject, wherein the analysis tool:
 sets forth a success percentage that is correlated with an AMH level based upon an applicable age group, 
 assigns the success percentage as applicable to a live birth rate, a live birth probability, a pregnancy rate with in vitro fertilization and a pregnancy probability with in vitro fertilization, and 
 categorizes the assigned success percentage into an associated grouping of the assigned success percentage for an applicable one of different prognosis categories; 
 
 making a diagnosis by retrieving the associated grouping from the accessed analysis tool so as to provide a prognosis for terminating pregnancy or increasing miscarriage rate in the subject; and 
 administering to the subject a composition having an effective amount of AMH protein in accord with the prognosis to achieve and maintain an AMH level that is higher than that of: 7.0 ng/ml for the subject being under 36 years old; and 6.5 ng/ml for the subject being 36-42 years old inclusive, 
 wherein the composition comprises SEQ ID NO: 1. 
 
     
     
       17. A method of decreasing a pregnancy rate in a subject, comprising:
 accessing an analysis tool that identifies an applicable one of different prognosis categories each containing a corresponding success percentage for an ascertained anti-Mü llerian hormone (AMH) level of a subject based upon the age of the subject, wherein the analysis tool:
 sets forth a success percentage that is correlated with an AMH level based upon an applicable age group, 
 assigns the success percentage as applicable to a live birth rate, a live birth probability, a pregnancy rate with in vitro fertilization and a pregnancy probability with in vitro fertilization, and 
 categorizes the assigned success percentage into an associated grouping for an applicable one of different prognosis categories; 
 
 making a diagnosis by retrieving the associated grouping from the accessed analysis tool so as to provide a prognosis for decreasing the pregnancy rate in the subject; and 
 administering to the subject a composition having an effective amount of AMH protein in accord with the prognosis to achieve and maintain an AMH level that is higher than that of: 8.5 ng/ml for the subject being under 36 years old; 7.5 ng/ml for the subject being 36-38 years old inclusive; 7.0 ng/ml for the subject being 39-42 years old inclusive; and 7.5 ng/ml for the subject being over 42 years old, 
 wherein the composition comprises SEQ ID NO: 1.